In 2017 Spain incorporated 80% of the cancer drugs approved by the EMA while in 2020 it was reduced to 36%; some of these with limitations according to the clinical picture.
Clinical trials, treatment improvements and the approval of new drugs are some of the key points that have allowed the survival of cancer patients, in general, and lung cancer, in particular, to increase. “At first the doctors did not give me any hope of life when they detected my cancer. In addition, the chemo did not help me to reduce the tumors. However, when they started giving me this new drug in a clinical trial nine years ago, everything began to come to a standstill. Since then I continue with the treatment and lead a normal life. This drug has meant giving me life,” says Antonio Redondo, a lung cancer patient at the Jiménez Díaz Foundation.
“Some of us know that half the medicines arrive in Spain than, for example, in Germany. We have to deal with this, there is no other option. Whoever has a lot of money can go to receive treatment there, but those who don’t have to wait and see what happens”, explains José Antonio, a patient at the Puerta de Hierro Hospital diagnosed with lung cancer in 2019.
The situation that patients find themselves with is that some medicines have full availability in the National Health System (SNS), while others are limited. That is, the patient must have a specific clinical framework for the treatment to be covered by the public system.
Of the 41 cancer drugs approved by the European Medicines Agency (EMA) in the 2017-2020 period, only 25 are available in Spain as of January 1, 2022. In addition, ten of these drugs have restricted availability to a box concrete clinical. Of the cancer drugs approved by the EMA in 2017, 80% arrived in Spain, 83% in 2018, 38% in 2019 and 36% in 2020. This translates into 44% fewer drugs incorporated into the National Health System in just four years. The figures place Spain behind countries like Portugal, France, England, Italy or Germany.
When the EMA approves a cancer drug, it has gone through multiple previous clinical trials, publications in scientific journals and congresses. Manuel Dómine, an oncologist from the Jiménez Díaz Foundation and the Spanish Lung Cancer Group (GECP) contextualizes: “Spain is one of the world leaders in participation and development of clinical trials. In this way, it collaborates in the approval of new drugs for the treatment of cancer”.
But once approved, it is not immediately incorporated into the national health system of each of the countries belonging to the EMA. European Community law (Council Directive 89/105/EEC of December 21, 1988) establishes that each member state will ensure that the total period of the procedure does not exceed 180 days.
Despite this, in Spain the average time that elapses from the time a drug is approved by the EMA until it becomes available is 517 days and 469 days in the case of drugs for cancer treatment. This last figure is lower than Portugal (753), but much higher than countries such as Germany (100), England (268), the Netherlands (270) or Italy (405), according to the Patients WAIT 2021 report. In France there is a average of 490 days, which would be less if the report took into account certain innovative products that the country allows to make available before being authorized. However, the average of the EMA, taking into account all the countries and not only the members of the EU, amounts to 545 days, since some Eastern European states register much higher averages than the rest.
Lack of transparency in price negotiation
“The path that drugs follow from the time they are approved by the EMA until they are suitable in Spain is unclear,” explains the head of the Medical Oncology Service at Hospital Puerta de Hierro in Madrid and president of GECP, Mariano Provencio. The laboratories are presented to the process and after this the Therapeutic Positioning Report (IPT) is published, which “should be in three months, but it usually takes up to nine months.” For Provencio, the IPTs do not improve anything or almost nothing and are even more restrictive, so they should go directly to negotiating the financing.
Once approved and appropriate to the indication presented, the price is negotiated. The debate on the table, according to Provencio, is that “if the European regulatory agency approves a medicine, the rest of the scientific questions that arise in each country must be subject to the indication by the EMA. Another very different thing, and where there is a lack of transparency, is in the price negotiation with the pharmaceutical companies. It does not make sense that in some countries it costs more and in others less. We find that they must negotiate the best price for the country according to their possibilities”.
The late arrival or non-arrival of cancer drugs in Spain could have a greater impact in future years. The World Health Organization (WHO) estimates that the incidence in Spain (in the case of new diagnoses of lung cancer) could increase up to 9.9% in 2025 compared to that registered in 2020
One in ten deaths are passive smokers
Tobacco is the causal factor of 90% of lung cancer cases. This is indicated by the radiologist Marcelo Sánchez. But not all people with this disease are smokers. In 2019, the WHO estimated that one in ten deaths related to tobacco corresponded to passive smokers in what is known as exposure to environmental tobacco smoke. “Currently, the risk of suffering from lung cancer in a person exposed to environmental tobacco smoke is 35% higher than the risk that a person who has never smoked may have,” explains Alberto Ruano, the professor of Preventive Medicine and Public Health. from the University of Santiago de Compostela.
Normally one thinks of continuous exposure to tobacco smoke in homes, forgetting that passive smoking can be done in the street, at the bus stop, on terraces, in closed vehicles, etc… which can become “determinant for the contraction of many other illnesses”, points out Ruano. That is why, since 2014, the European Code against Cancer recommends that the population avoid tobacco consumption, but also exposure to environmental tobacco smoke.
The percentages might not seem alarming if the extremely high incidence of these diseases is not taken into account. The scarcity of information in the last decade should take the issue back to 2011, when studies calculated that in Spain between 1,000 and 1,500 people died each year as a result of passive exposure to tobacco. This figure rose to 600,000 worldwide, as reported by the WHO in 2019.
The concentration and duration of environmental tobacco smoke exposure are the two key factors to consider. “Imagine that I am a smoker, but I smoke one cigarette a day. However, another person does not smoke, but his partner consumes 30 cigarettes a day and lives in a very small apartment. So her lung will probably be more affected than mine could be, ”exemplifies the professor. And he offers a striking picture of the situation by stating that, to date, he knows of no way to differentiate the lung cancer lungs of an active smoker from those of a passive smoker.
In Spain, Law 42/2010, of December 30, modified the old Law of 28/2005, of December 26, on sanitary measures against smoking and regulating the sale, supply, consumption and advertising of tobacco products. From this law, smoking was prohibited in closed spaces. However, Ruano defends that “the law has become obsolete. It is necessary to reformulate it again to make it more restrictive”. As of today, a new law is on the table that will prohibit smoking on the terraces of bars and restaurants, sports stadiums, parks and beaches, among other modifications. Alba Garcia de la Gama/Tomas Alvarez Millan.